Efficacy of endoscopic transantral versus transorbital surgical approaches in the repair of orbital blowout fractures: study protocol for a randomized controlled trial

Abstract

Background: Repair of orbital blowout fractures faces a lot of complications and difficulties to restore and reconstruct the exact position of the orbital bony skeleton especially at the orbital rims, and also a difficulty in restoring the functions of the orbital soft contents such as the muscles, the globe and the lacrimal system. Methods/Design: This prospective randomized controlled trial with a two-arm, parallel-group structure evaluating the efficacy of endoscopic transantral surgical versus traditional transorbital surgical approaches in the treatment of orbital blowout fractures will be conducted at Faculty of Oral and Dental Medicine, Cairo University, Giza, Egypt. Thirty-eight patients with diplopia due to orbital blowout fracture will be recruited. All patients will undergo CT, pulse test, and forced duction test. The primary outcome measure is the diplopia resolution detected intraoperatively via forced duction test. The secondary outcomes include the enophthalmos correction, preservation of orbital floor periosteum and exacting/equalization of the injured bony level on the non-injured side. Discussion: The results of the trial will support better decision-making for surgical treatment in orbital blowout fractures. Trial registration: ClinicalTrials.gov identifier: NCT03011047 registered on January 4, 2017. Ethics: This protocol and the template informed consent form was approved by the Ethics Committee of Scientific Research, Faculty of Oral and Dental Medicine, Cairo University, Egypt (February 2017). Informed consent: Written informed consent will be obtained from all participants prior to the trial.